CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report

G6 Continuous Glucose Monitoring System The Dexcom G4 recalled

Dexcom is recalling G6 Continuous Glucose Monitoring System The Dexcom G4 Platinum Continuous Glucose. The recall was initiated on 3 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice Listing Number: D319131 Model: STS-OR-003 Description: G6 Sensor Kit 3 Pack GUDID Registered GTIN: 50386270000250 Lot Number: All Model: STS-OE-003 Description: G6 Sensor Kit 3 Pack Retail GUDID Registered GTIN: 00386270000866 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Medicare GUDID Registered GTIN: 00386270001047 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Pro Q GUDID Registered GTIN: 70386270000254 Lot Number: All

Quantity recalled275583

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1562-2020
FDA event ID: 84891
Recalling firm: Dexcom, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Feb 2020
FDA classified: 25 Mar 2020
Reported: 1 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Foreign Material
Device type: Insulin Pumps & Glucose Monitors

Timeline

3 Feb 2020	Recall initiated by company
25 Mar 2020	Classified by FDA	+51 days
1 Apr 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

Where it was distributed

World-wide Distribution

Questions about this recall

Why was it recalled?

The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

Which lots are affected?

Device Listing Number: D319131 Model: STS-OR-003 Description: G6 Sensor Kit 3 Pack GUDID Registered GTIN: 50386270000250 Lot Number: All Model: STS-OE-003 Description: G6 Sensor Kit 3 Pack Retail GUDID Registered GTIN: 00386270000866 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Medicare GUDID Registered GTIN: 00386270001047 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Pro Q GUDID Registered GTIN: 70386270000254 Lot Number: All

Where was it sold?

World-wide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 84891

Reported	Class	Recall	Company	Reason	Where
1 Apr 2020	CLASS II	G4 Platinum Continuous Glucose Monitoring System The Dexcom recalled	Dexcom	Foreign Material	CA
1 Apr 2020	CLASS II	G5 Continuous Glucose Monitoring System The Dexcom G4 recalled	Dexcom	Foreign Material	CA

More recalls from Dexcom

All 29

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalled	Dexcom	Device Malfunction	CA
20 May 2026Device	CLASS II	ONE+ iOS CGM App recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled	Dexcom	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled	Dexcom	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS I	G6 Continuous Glucose Monitoring System Dexcom G6 recalled	Dexcom	Device Malfunction	Nationwide

Other Insulin Pumps & Glucose Monitors recalls

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14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
6 Oct 2026Device	ANNOUNCED	StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip	Nova Biomedical	Device Malfunction
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide